Shilpa Medicare Limited
FDA Compliant • GMP Certified

Formulation Development

From Concept to Commercial

We develop and manufacture a wide range of oral, injectable, topical and specialty formulations — guiding your product from concept through scale-up to commercial cGMP production.

Immediate Release Tablets
Modified Release Systems
Oral Liquid Formulations
Sterile Injectables
Topical Preparations
Specialty Dosage Forms
Formulation Development
500+
Formulations Developed
15+
Dosage Forms

Our Formulation Development Process

Pre-formulation

API characterization, excipient compatibility and risk assessment.

Development

Prototype formulation, optimization and robustness studies.

Scale-up

Pilot and validation batches with process optimization.

Manufacturing

cGMP commercial manufacturing with in-house quality control and QA.

Formulation Development Excellence

Our formulation team develops a comprehensive range of dosage forms across multiple therapeutic areas, adhering to global quality and regulatory standards. With state-of-the-art facilities and a strong track record in complex and oncology products, we transform molecules into safe, effective and patient-centric medicines.

Core Capabilities

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Generic Drug Development

Expertise in developing both oncology and non-oncology generics using advanced manufacturing technologies and robust quality systems.

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Differentiated Products

Value-added formulations designed for product differentiation, lifecycle management and improved patient outcomes.

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Drug Repurposing

Formulation strategies that enable existing molecules to address new therapeutic indications.

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Clinical Programs

Development strategies that balance data needs with prudent human exposure, supporting efficient clinical progression.

Regulatory Excellence

Extensive experience in engaging with global regulatory agencies and addressing development challenges proactively to keep projects on track.
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